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RECRUITING
NCT06516653
NA

Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

Sponsor: Laminate Medical Technologies

View on ClinicalTrials.gov

Summary

VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula

Official title: Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-01-13

Completion Date

2028-05

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

DEVICE

VasQ

External support implant for the arteriovenous fistula

PROCEDURE

Arteriovenous fistula creation for dialysis vascular access

End to side fistula creation in the arm for dialysis vascular access

Locations (7)

Fresenius Vascular Care Long Beach

Long Beach, California, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Greenwood Leflore Hospital

Greenwood, Mississippi, United States

Azura Surgery Center Las Vegas

Las Vegas, Nevada, United States

Fresenius Vascular Care Columbia

Columbia, South Carolina, United States

Fairlawn Surgery Center

Roanoke, Virginia, United States